////////////////////////////////////////////////////////////////////
DEVICE /
RAC
/ /
EXAM
/ /
QUESTIONS WITH CORRECT ANSWERS
/ // // //
Which /
/division /
/would /
/have /
/primary /
/jurisdiction //over //a //vascular //graft //with //an //antibiotic //based //on //primary //mode //of //action?
A. //CDER
B. //CBER
C. //CDRH
D. //OCP //- //correct //answer(s) //✔✔ //C
A/
/company /
/wants /
/to /
/modify /
/its //legally //marketed //device //such //that //the //modification //does //not //affect //the //intended //use
//or /
/alter /
/the /
/fundamental /
/scientific /
/technology /
/of /
/the /
,////////////////////////////////////////////////////////////////////
/device. /
/If /
/the /
/design /
/outputs /
/of //the //modified //device //meet //the //design //input //requirements, //this //change //would //be //best
//filed //as //a(n):
A. //Special //510(k)
B. //Abbreviated //510(k)
C. //Traditional //510(k)
D. //De //novo //510(k) //- //correct //answer(s) //✔✔ //A
Under /
/the /
/statutory /
/violations, /
/failure /
/to /
/meet /
/510(k) /
/requirements /
/for //
a/
/device //that //is //required //to //have //a //510(k) //and //is //in //commercial //distribution //is //considered
//to //be:
A. //Adulteration.
B. //Improper //use
C. //Misbranded
D. //Fraudulent //- //correct //answer(s) //✔✔ //C
A/
/company's /
,////////////////////////////////////////////////////////////////////
/competitor /
/is /
/marketing //
a/
/Class /
/II /
/suture /
/which /
/dissolves /
/during /
/the /
/third /
/week /
/of /
/use. /
/The /
/company's /
/current /
/product /
/has /
/to /
/be /
/removed //by //a //physician. //However, //a //change //in //weaving //configuration //gives //this //product
//the /
/same /
/dissolving /
/time //as //the //competitor's. //When //can //the //company's //new //suture //be //marketed?
A. //This //requires //a //new //510(k) //since //significant //change //in //product //instructions //might
affect //efficacy.
B. //After //submission //in //a //periodic //report
C. //After //reporting //clinical //studies //in //an //annual //report
D. //After //submission //of //labeling //change //- //correct //answer(s) //✔✔ //A
, ////////////////////////////////////////////////////////////////////
Which //of //the //following //is //exempt //from //GMP/QSR //regulations?
A. //Remanufacturers
B. //Custom //device //manufacturers
C. //Repackagers
D. //Component //manufacturers //- //correct //answer(s) //✔✔ //D
A //physician //reports //to //a //manufacturer //that //a //patient //was //hospitalized //with //acute //sepsis
//after /
/treatment /
/with /
/an /
/approved /
/device. //This //side //effect //is //not //listed //in //the //package //insert. //This //event //must //be //reported
//by //the //manufacturer //to //FDA //no //later //than:
A. //5 //calendar //days
B. //15 //calendar //days
C. //30 //calendar //days
D. //The //next //quarterly //or //annual //report //- //correct //answer(s) //✔✔ //C
If //
a/
/device /
/failure /
/is /
/occurring /
/with /
/greater /
/than /
/expected /
/frequency /
/and /
/investigation /
DEVICE /
RAC
/ /
EXAM
/ /
QUESTIONS WITH CORRECT ANSWERS
/ // // //
Which /
/division /
/would /
/have /
/primary /
/jurisdiction //over //a //vascular //graft //with //an //antibiotic //based //on //primary //mode //of //action?
A. //CDER
B. //CBER
C. //CDRH
D. //OCP //- //correct //answer(s) //✔✔ //C
A/
/company /
/wants /
/to /
/modify /
/its //legally //marketed //device //such //that //the //modification //does //not //affect //the //intended //use
//or /
/alter /
/the /
/fundamental /
/scientific /
/technology /
/of /
/the /
,////////////////////////////////////////////////////////////////////
/device. /
/If /
/the /
/design /
/outputs /
/of //the //modified //device //meet //the //design //input //requirements, //this //change //would //be //best
//filed //as //a(n):
A. //Special //510(k)
B. //Abbreviated //510(k)
C. //Traditional //510(k)
D. //De //novo //510(k) //- //correct //answer(s) //✔✔ //A
Under /
/the /
/statutory /
/violations, /
/failure /
/to /
/meet /
/510(k) /
/requirements /
/for //
a/
/device //that //is //required //to //have //a //510(k) //and //is //in //commercial //distribution //is //considered
//to //be:
A. //Adulteration.
B. //Improper //use
C. //Misbranded
D. //Fraudulent //- //correct //answer(s) //✔✔ //C
A/
/company's /
,////////////////////////////////////////////////////////////////////
/competitor /
/is /
/marketing //
a/
/Class /
/II /
/suture /
/which /
/dissolves /
/during /
/the /
/third /
/week /
/of /
/use. /
/The /
/company's /
/current /
/product /
/has /
/to /
/be /
/removed //by //a //physician. //However, //a //change //in //weaving //configuration //gives //this //product
//the /
/same /
/dissolving /
/time //as //the //competitor's. //When //can //the //company's //new //suture //be //marketed?
A. //This //requires //a //new //510(k) //since //significant //change //in //product //instructions //might
affect //efficacy.
B. //After //submission //in //a //periodic //report
C. //After //reporting //clinical //studies //in //an //annual //report
D. //After //submission //of //labeling //change //- //correct //answer(s) //✔✔ //A
, ////////////////////////////////////////////////////////////////////
Which //of //the //following //is //exempt //from //GMP/QSR //regulations?
A. //Remanufacturers
B. //Custom //device //manufacturers
C. //Repackagers
D. //Component //manufacturers //- //correct //answer(s) //✔✔ //D
A //physician //reports //to //a //manufacturer //that //a //patient //was //hospitalized //with //acute //sepsis
//after /
/treatment /
/with /
/an /
/approved /
/device. //This //side //effect //is //not //listed //in //the //package //insert. //This //event //must //be //reported
//by //the //manufacturer //to //FDA //no //later //than:
A. //5 //calendar //days
B. //15 //calendar //days
C. //30 //calendar //days
D. //The //next //quarterly //or //annual //report //- //correct //answer(s) //✔✔ //C
If //
a/
/device /
/failure /
/is /
/occurring /
/with /
/greater /
/than /
/expected /
/frequency /
/and /
/investigation /
